A Study of SHR-4610 Injection in Patients With Advanced Solid Tumors
ConditionSolid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Shengdi Pharmaceutical Co., Ltd
About this trial
This study is an open, multicenter Phase I/II clinical trial, divided into two stages: dose exploration (including dose escalation and dose extension) and efficacy extension.
Eligibility criteria
Qualifiers
Subjects must voluntarily agree to participate in the trial and sign a written informed consent form;
Age range: 18-75 years old, both male and female are welcome;
Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment;
Have at least one measurable tumor lesion per RECIST v1.1;
Disqualifiers
Patients with active central nervous system metastases or meningeal metastases;
Systemic antitumor therapy was received 4 weeks before the start of the study;
Moderate or severe ascites with clinical symptoms; Uncontrolled or moderate or higher pleural effusion or pericardial effusion;
Have poorly controlled or severe cardiovascular disease;
Trial design
Treatments tested in this trial
- SHR-4610 Injection
Treatment groups
258 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov